Treatment of Atrophic Post Acne Scars by Fat Grafting

NCT05028283 | Completed

• 1 other identifier: UDMS-Derma-01-2021
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, clinical trial consists of a one autologous fat grafting treatment followed by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the efficacy and complications of fat grafting when used for facial atrophic acne scars on cheeks.

Conditions

Atrophic Acne Scars

Keywords

Acne- atrophic scars - autologous fat

Outcome Measures

Primary Outcomes (2)

• • Change in atrophic acne scars assessment

  Acne scars will be used to evaluate efficacy of treatment using the Goodman- Barron scale \[which is an acne scars severity scale divided into 4 grades * First grade consists of hyper-or hypopigmented flat marks * Second grade consists of mild atrophy or hypertrophy that may not be obvious at social distances of 50 cm or greater and may be covered adequately by makeup * Third grade consists of moderate atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow * Fourth grade severe atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow\]. The grade of acne scars from final visit will be compared to their baseline grade visually evaluated by the study team.

  Baseline and 6 Months

• Change in patient satisfaction

  The modified global aesthetic improvement scale for patient evaluation module which consists of 5 degrees * Exceptionally improved \[The ideal result has been achieve\] * much improved\[The result is much improved but suboptimal\] * Improved\[The result is improved but an additional procedure is recommended \] * no difference\[The result is the same when compared with the preoperative state\] * Worse\[The result is worse when compared with the preoperative state\] This module will be administered 3monts and 6 months postoperatively to analyze satisfaction and aesthetic perception of the result.

  3 Months, and 6 Months

Secondary Outcomes (5)

• Change in Infection existence

  1 week, 1 month, 3 months and 6 Months

• Change in Bruising Status

  Baseline ,1 week 1 month,3 months and 6 Months

• Change in Erythema Presence

  Baseline ,1 week ,1 month,3 months and 6 Months

• Change in Swelling Status

  Baseline ,1 week 1month,3 months and 6 Months

• Change in Irregularity Presence

  Baseline and 6 Months

Study Arms (1)

participants

EXPERIMENTAL

patients with atrophic acne scars on the cheeks who will reviewing the dermatological clinics at the Dermatology and Venereology Hospital at least 69 patients they will be undergo fat grafting for one session and will be follow up for 6 months after the procedure

Procedure: Fat Grafting

Interventions

Fat Grafting PROCEDURE

This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with atrophic acne scars on the cheeks

participants

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with atrophic post acne scars on the cheeks, between 20 - 40 years old
• Not to apply other treatments a month before the procedure
• Informed consent to enter the study

You may not qualify if:

• First grade of Goodman - Barron scale.
• A systemic or associated skin disease that may affect the results of the study
• patients with chronic consumption of nonsteroidal anti-inflammatory drugs (NSAIDs) or other non-aggregating agents.
• Patients with acne in the acute stage
• Pregnancy and breastfeeding
• Tendency to form keloids

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Dermatology and Venereology Hospital

Damascus, Syria

Location

Related Publications (11)

• Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.

  PMID: 21880356 BACKGROUND

• Goulden V, McGeown CH, Cunliffe WJ. The familial risk of adult acne: a comparison between first-degree relatives of affected and unaffected individuals. Br J Dermatol. 1999 Aug;141(2):297-300. doi: 10.1046/j.1365-2133.1999.02979.x.

  PMID: 10468803 BACKGROUND

• Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.

  PMID: 30856634 BACKGROUND

• Thiboutot D, Gollnick H, Bettoli V, Dreno B, Kang S, Leyden JJ, Shalita AR, Lozada VT, Berson D, Finlay A, Goh CL, Herane MI, Kaminsky A, Kubba R, Layton A, Miyachi Y, Perez M, Martin JP, Ramos-E-Silva M, See JA, Shear N, Wolf J Jr; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009 May;60(5 Suppl):S1-50. doi: 10.1016/j.jaad.2009.01.019.

  PMID: 19376456 BACKGROUND

• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

  PMID: 11304456 BACKGROUND

• Coleman SR. Facial augmentation with structural fat grafting. Clin Plast Surg. 2006 Oct;33(4):567-77. doi: 10.1016/j.cps.2006.09.002.

  PMID: 17085224 BACKGROUND

• Zeltzer AA, Tonnard PL, Verpaele AM. Sharp-needle intradermal fat grafting (SNIF). Aesthet Surg J. 2012 Jul;32(5):554-61. doi: 10.1177/1090820X12445082.

  PMID: 22745443 BACKGROUND

• Lindenblatt N, van Hulle A, Verpaele AM, Tonnard PL. The Role of Microfat Grafting in Facial Contouring. Aesthet Surg J. 2015 Sep;35(7):763-71. doi: 10.1093/asj/sjv083. Epub 2015 Jun 2.

  PMID: 26038369 BACKGROUND

• Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.

  PMID: 23783059 BACKGROUND

• Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.

  PMID: 17199653 BACKGROUND

• Sezgin B, Ozmen S. Fat grafting to the face with adjunctive microneedling: a simple technique with high patient satisfaction. Turk J Med Sci. 2018 Jun 14;48(3):592-601. doi: 10.3906/sag-1711-42.

  PMID: 29914257 BACKGROUND

Study Officials

• Rahaf Alkhouli, MSc

  Dermatology Department, University of Damascus Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: August 19, 2021
• Primary Completion: August 19, 2023
• Study Completion: October 20, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)